Regulatory Affairs Liaison Oncology

Orion Group ,
High Wycombe, Buckinghamshire
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Overview

Orion Group Life Sciences have an exciting opportunity for a Regulatory Affairs Liaison (Oncology) for our Multinational Pharmaceutical client based in the Buckinghamshire area on an initial 6-month contract. Main Responsibilities of the role Strategic and tactical input in development, post-approval and Life cycle management Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates Drive understanding of central and national regulatory requirements Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labelling Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings Determine timing and strategy for Regulatory Agency meetings and scientific advice Define attendance in consultation with GRL and CDT. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies Negotiate labeling with Regulatory Agencies, going through each of the back-up strategies if necessary Advise team on required documents and processes to support Regulatory Agency contacts and submission Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory Agency questions Clinical Trial Applications (CTA): Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labelling Advise team on required documents and submission strategies in preparation of CTA Ensure CTA submission packages are complete and available according to agreed timelines Marketing Authorization Application (MAA): Provide regulatory support throughout registration process Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate) Ensure timely MAA availability, track critical path activities Responsible for submission and acceptance of MAA Ensure country-specific submission packages are made available to the LOCs Determine resource requirements for assigned projects and anticipate needs for major filing Desired Experience and Background of the successful candidate University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas) In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions Experience with EU regulatory procedures (CP, MRP, national) Experience in working in project teams and/or a matrix organization Previous Oncology experience required/ Knowledge of the applicable therapeutic area Negotiating and conflict handling skills/People management skills Complex project management skills Excellent knowledge of English Pharmaceutical medical drug multinational product RegulatoryAffairs CTA Oncology For more information on this role, call Callum Crowe on 44 (0) 2039944696 or email for a completely confidential chat about this role and other opportunities using the reference number: 930541 Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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